October 2, 2000 - pSMILE
|Occurrence Management Policy |Policy Number |Doc10-14AppH |
| |Effective Date |30-Jul-08 |
|Approval Signature: Laboratory Director |Supersedes |New |
|Last Review |10-Feb-20 |Review by |Heidi Hanes |
|SMILE Comments: This document is provided as an example only. It must be revised to accurately reflect your lab’s specific processes and/or |
|specific protocol requirements. Users are encouraged to ensure compliance with local laws and study protocol policies when considering the |
|application of this document. If you have any questions contact SMILE. |
QSE 8: Occurrence Management - Policy
|Policy |The laboratory identifies, documents, and investigates occurrences (nonconformances); classifies, analyzes, and |
| |trends the information they represent; performs remedial/corrective actions; and identifies the need for root |
| |cause analysis and process improvement. |
|Purpose |This policy provides direction for the processes and procedures to effectively detect and resolve problems and to|
| |classify problems so that corrective actions aimed at removing root causes and improving processes can be planned|
| |and implemented. |
|Responsibility |The Laboratory Supervisor is responsible for problem resolution and investigations. |
| |The Quality Manager and Quality Management Team are responsible for collecting and analyzing occurrence data. |
| |The Lead Technologists are responsible for documentation of complaints and problem resolution. |
|Identifying Occurrences |The laboratory has a means to identify, document, investigate, and respond to complaints from internal/external |
| |customers; recalls of materials, equipment, or software; and other nonconforming events. |
|Investigation and Response to |The laboratory has a procedure for identifying, documenting, and investigating occurrences and performing |
|Occurrences |remedial and corrective actions in response to those nonconforming events. |
|Classifying and Analyzing |The laboratory has a procedure for classifying and analyzing occurrences, including trending information, so that|
|Occurrence Information |the portions of the path of workflow with the most important patient-related and costly problems can be |
| |identified, corrected, and referred for root cause analysis and process improvement. |
|Supporting Documents |The following processes support this policy: |
| |Identifying and Documenting Occurrences |
| |Remedial Actions and Investigation of Occurrences |
| |Analyzing Occurrence Information and Referring for Root Cause Analysis and Process Improvement |
Identifying and Documenting Occurrences - Process
Process for Identifying and Documenting Occurrences
|What Happens |Who’s Responsible |Procedures |
|The laboratory identifies or receives |Laboratory Supervisor |Communication of Safety and Quality Concerns|
|complaints from internal and external |Quality Manager | |
|customers |Technicians/Technologists | |
| |External Customers | |
|The laboratory receives recalls or |Laboratory Supervisor |Inventory Management |
|notification of nonconformances as related to|Laboratory Supply Manager |Communication of Safety and Quality Concerns|
|materials, equipment, or software | | |
|A nonconforming event is identified from |Laboratory Director |Audit-Related SOPs |
|internal/external audits, QC/Calibration/EQA |Laboratory Supervisor |EQA SOPs |
|failures, or management reviews |Quality Manager |Quality Management |
| |Technicians/Technologists |Communication of Safety and Quality Concerns|
|The occurrence is documented on appropriate |Laboratory Supervisor |Communication of Safety and Quality Concerns|
|electronic or paper-based occurrence report |Quality Manager | |
|form |Technicians/Technologists | |
|The form is submitted to the designated |Laboratory Supervisor |Communication of Safety and Quality Concerns|
|individual for further action, including |Quality Manager |Quality Management |
|remedial/corrective actions, root cause |Technicians/Technologists |Process Improvement |
|analysis, and process improvement | |Remedial and Corrective Actions |
Remedial Actions and Investigation of Occurrences - Process
Process for Remedial Actions and Investigation of Occurrences
|What Happens |Who’s Responsible |Procedures |
|Immediate remedial actions are initiated to |Laboratory Supervisor |Communication of Safety and Quality Concerns|
|resolve any immediate concerns related to |Quality Manager |Investigations of Occurrences |
|patient care |Technicians/Technologists |Remedial and Corrective Actions |
|Remedial actions are documented on the |Laboratory Supervisor |Investigations of Occurrences |
|occurrence report form |Quality Manager |Quality Management |
| |Technicians/Technologists |Remedial and Corrective Actions |
|The occurrence is investigated and |Laboratory Supervisor |Investigations of Occurrences |
|documentation is completed |Quality Manager |Quality Management |
| |Quality Management Team | |
|Additional corrective or preventive actions are|Laboratory Supervisor |Investigations of Occurrences |
|completed and documented |Quality Manager |Quality Management |
| |Quality Management Team |Technical SOPs |
| |Technicians/Technologists |Remedial and Corrective Actions |
|Occurrence report form is submitted to |Laboratory Supervisor |Quality Management |
|designated individual for additional occurrence|Quality Manager |Process Improvement |
|analysis |Quality Management Team | |
Analyzing Occurrence Information and Process Improvement Referral - Process
Process for Analyzing Occurrence Information and Process Improvement Referral
|What Happens |Who’s Responsible |Procedures |
|Information regarding individual occurrences is|Quality Manager |Communication of Safety and Quality Concerns |
|entered into an electronic or paper-based |Quality Management Team |Occurrence Report Forms |
|database | |Quality Management |
| | |Occurrence Data Analysis |
| | |Process Improvement |
|Occurrences are categorized, tracked, and |Quality Manager |Occurrence Data Analysis |
|organized in a manner to facilitate analysis of|Quality Management Team |Quality Management |
|collective data | |Process Improvement |
|Database and occurrence report information are |Quality Manager |Occurrence Data Analysis |
|reviewed at regular intervals to identify |Quality Management Team |Quality Management |
|trends in occurrence information | |Process Improvement |
|Management reviews data and allocates resources|Quality Manager |Quality Management |
|for root cause analysis and process improvement|Quality Management Team |Occurrence Data Analysis |
| |Laboratory Management |Process Improvement |
| | |Allocation of Resources |
................
................
In order to avoid copyright disputes, this page is only a partial summary.
To fulfill the demand for quickly locating and searching documents.
It is intelligent file search solution for home and business.
Related download
- basic counseling skills
- risk management involves identifying analyzing
- the historical context of emergency management
- comparing domestic foreign policy in the 1940s 1950s
- october 2 2000 psmile
- critical incident response plan for first responders
- econ 201 exams 1 twomey um d
- the entrepreneurial mindset strategies for continuously
Related searches
- important events 2000 to 2017
- 2000 bad credit loan guaranteed
- 2000 emergency loan bad credit
- 2000 west creek apartments richmond
- 2000 loan no credit check
- blackrock 2000 chart
- historical events 2000 to 2014
- 2000 loan with bad credit
- 2000 5.4 triton engine diagram
- historical events timeline 2000 present
- 2000 to 2010 historical events
- in 2000 the demand for nurses was 2 000 000